Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices:

• OMB Approval for Form Changes Underway - Continue to Use Current Forms Until Further Notice
• (NOT-OD-15-146) National Institutes of Health
• eRA Commons Help Desk Rebranded as eRA Service Desk
• (NOT-OD-15-147) National Institutes of Health

Requests for Applications:

• Abuse Liability Associated with Reduced Nicotine Content Tobacco Products (R01)
• (RFA-OD-15-006)
• Office of Disease Prevention
• U.S. Food and Drug Administration, Center for Tobacco Products
• National Cancer Institute
• National Heart, Lung, and Blood Institute
• Eunice Kennedy Shriver National Institute of Child Health and Human Development 
• National Institute on Drug Abuse
• Application Receipt Date(s): December 11, 2015

Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

Many American cities are distinctly shaped by ties to other parts of the world. Washington has its Ethiopian community, and the restaurants that have come with it. Chicago has its Mexican neighborhoods, Minneapolis its Hmong culture, Miami its links to Cuba.

These differences — products of proximity or history or happenstance — are part of what makes New York feel culturally different from Atlanta. And they reflect the fact that New York and Atlanta look different to people living abroad.

Baltimore's tech scene will get some time in the spotlight later this month when Steve Case's "Rise of the Rest" tour rolls into town. The five-city roadshow, through which the AOL co-founder and former CEO plans to invest $1 million in early-stage technology ventures, kicks off in Baltimore on Sept. 28.

The bus tour, which is designed to bring attention and funding to startups beyond traditional tech hubs like Silicon Valley or New York City, will also give Johns Hopkins University a chance to show the part it plays in supporting Baltimore's bubbling culture of tech innovation.

Preparations are underway for a new hackathon focused on health and technology.

The first edition of MedHacks will be held Oct. 2-4 at the Bloomberg Center for Physics and Astronomy on the JHU Homewood Campus.

Following a $2 billion merger between DTZ and Cushman & Wakefield, David Gillece will head up the firm's newly combined offices in Baltimore.

Gillece was regional managing principal with DTZ and before that held the same position with brokerage Cassidy Turley, which combined with DTZ last year.

Product development of any kind is challenging and full of unknowns, obstacles and pivots.

Medical device product development is certainly no different.

With med devices, when you throw in regulatory bodies, such as FDA and others internationally, it only complicates matters further.

University of Maryland Medicine (the University of Maryland Medical Center and the University of Maryland School of Medicine) and its Center for Metabolic Imaging and Image-Guided Therapeutics (CMIT) has begun to use MRI-guided focused ultrasound on a deep structure within the brain related to Parkinson's disease - the globus pallidus.

In the first clinical trial of its kind, researchers from the Departments of Diagnostic Radiology & Nuclear Medicine, Neurosurgery and Neurology at CMIT are using magnetic resonance imaging (MRI) to guide ultrasound waves through the intact skin and skull to the globus pallidus. The University of Maryland is one of only two sites in the United States to offer this treatment to Parkinson's patients.

ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, today announced that it has raised $80 million through a private placement of equity. New investors include leading European and US-based investors alongside founding investor Auven Therapeutics and participation from AstraZeneca.

The proceeds will be used to progress ADCT’s product portfolio, including ADCT-301 for lymphoma and leukemia now in Phase I and a collaboration to develop up to two ADCs for commercialisation with MedImmune, the global biologics research and development arm of AstraZeneca. ADCT’s ADCs are highly targeted drug constructs which combine monoclonal antibodies specific to surface antigens on particular tumor cells with highly potent pyrrolobenzodiazepine (PBD)-based warheads. ADCT anticipates having seven drug candidates in human clinical trials in 2017.

D.C.-based startup incubator 1776, which filed with regulators last year to raise its first seed fund, announced Tuesday it has closed the fund at $12.5 million, half of what it had expected to raise.

1776 has backed 20 companies since launching the fund, co-investing with other groups including 500 Startups, Silicon Valley Angels and GovTech Fund. The fund typically invests an average of $100,000 in pre-Series A startups focused on highly regulated industries, such as health, education, energy and transportation.

University of Maryland, Baltimore County, and Johns Hopkins University are among 12 universities that will share a $20 million grant for groundbreaking nanotechnology research.

The institutions are all part of the Center for Sustainable Nanotechnology at the University of Wisconsin-Madison. The five-year, $20 million grant from the National Science Foundation will support the center research of how nanoparticles interact with live beings and the environment.

Synthetic Biologics, a microbiome-focused clinical-stage biotechnology company, is moving its offices to the Johns Hopkins University Montgomery County Campus. Synthetic Biologics previously had its corporate headquarters at the VisArts incubator space in downtown Rockville but is moving its staff of 15 to the JHU campus, with plans to add more staff members in the future. The company has its administrative and financial offices in Ann Arbor, Mich.

The company is developing drugs to protect the gut microbiome in an effort to maintain the natural balance of bacteria in the gastrointestinal tract, which is important to our overall health, said Kris Maly, the company’s vice president of corporate communications.

A lot of time, effort and money goes into the creation of new drugs. A new game Big Pharma, which came out Thursday, is giving users the opportunity to see for themselves by running a virtual pharmaceutical company.

Not unlike Big Pharma in real life, one of your biggest priorities is money. It’s up to you whether or not you want to sacrifice efficacy to make cheaper products and yield more profit.

A digital health fund to invest in Israeli digital health startups recently made its first investment — Intendu. The company provides a way for people with neurological problems stemming from traumatic brain injury to age-related cognitive decline to train the brain through a series of personalized exercises that involve body-controlled adaptive videogames. The goals are customized to each user.

Partners for digital health venture fund eHealth Ventures include Cleveland Clinic Innovations, which is providing resources to the company in exchange for equity, and one of Israel’s largest HMOs, Maccabi Healthcare, are also supporting the fund.

A Madison-based research hub devoted to evaluating the environmental effect of nanotechnology has received $20 million in National Science Foundation funding over the next five years.

The University of Wisconsin-Madison is the host institution for the Center for Sustainable Nanotechnology, led by Robert Hamers, a chemistry professor at UW-Madison whose research has helped spawn a spinoff company focusing on building more powerful and more stable batteries for hybrid cars and electric vehicles.

Google is making another move into the profitable sphere of diabetes management: Its Life Sciences arm—which will soon fall under Google's new parent company, Alphabet—is announcing a partnership with Sanofi, a French pharmaceutical company, to build new treatment products for diabetes. The two firms will collaborate on product development and new methods for monitoring the condition.

Vaxin Inc., a clinical stage immunotherapy and vaccine company, today announced that it has changed its corporate name to Altimmune, Inc. Vaxin was founded in 1997 to pioneer new-generation vaccine technologies and products. Since then, the company has achieved steady success, developing promising vaccine candidates for biodefense and other public health needs, as well as animal health. In a strategic growth move earlier this year, the company acquired UK-based Immune Targeting Systems (ITS) and added prominent new investors to its syndicate. The acquisition vaulted Vaxin into the immunotherapeutics sector, growing its therapeutics expertise, expanding its market, and broadening its global footprint. The new name marks the next chapter for the newly combined company.

“The Vaxin brand has served as a superb ambassador of our vaccine product family, but the expansion of our product platform calls for a new brand,” said president and CEO, Bill Enright. “The name Altimmune reflects the novel solutions we bring to the broader biotech marketplace today. Bold emphasis on the immune system is intentional; it speaks to alternative therapies that stimulate immune responses for prevention and treatment of diseases. With some of today’s most exciting research discoveries happening in this area, our new name conveys a promise to deliver essential innovation to the space.”

Since Congress passed the 21st Century Cures Act on July 10th, one Big Pharma company has already moved to capitalize on the legislation even before it has been passed by the Senate and become law. A good introduction to the bill can be found in this piece. In short, the bill is designed to speed up the route to market for certain therapeutics. Senate passage is estimated for around December. In the last piece I paid particular attention to one of the most consequential aspects of the Act - that it would promote the development of brand-new antibiotics. In response to the Act, there have been two interpretations of this likely influx of therapeutics.

Transplant surgeons have started using a device that allows them to “reanimate” hearts from people who have recently died, and use the organs to save others. 

The “heart in a box” is a wheeled cart with an oxygen supply, a sterile chamber, and tubing to clamp onto a donor heart and keep it fed with blood and nutrients. Doctors say it may extend the time a heart can last outside the body and is letting them recover hearts from donors who haven’t been eligible before.

If there’s one thing that’s a nearly universal anxiety among cities, it’s brain drain, or the loss of educated residents to other places. I’ve written about this many times over the years, critiquing the way it is normally conceived.

Since brain drain seems to be a major concern in shrinking cities, I decided to take a look at the facts around brains in those places. Looking at the 28 metro areas among the 100 largest that had objective measures of shrinkage – in population and/or jobs – between 2000 and 2013, I looked what what happened to their educational attainment levels.

Remedy Pharmaceuticals, a company focused on the development and commercialization of CIRARA™, a breakthrough drug for treating acute central nervous system conditions, announced that a prospective multi-center open-label pilot study of CIRARA in patients with acute traumatic cervical spinal cord injuries. 

Mark Lafferty has joined UM Ventures Baltimore as a venture associate. In this role, he provides financing and business planning advice to new companies, prepares valuations for startup companies and new products, and evaluates financial aspects and terms for licensing deals.

Wednesday, September 16, 2015 12:00 pm-1:15 pm, Silver Spring Innovation Center, 8070 Georgia Avenue, Silver Spring, MD 20910

The Angel Venture Forum is starting up its annual educational training series to prepare business owners to make their pitches in front of 30 angel investors on November 10 at the National Press Club.  Angel investor Valerie Gaydos will explain the process and give a few highlights from the training series. Learn the six basic lessons that every entrepreneur should know and what investors want to know about you before investing:  1) Funding 2) Term Sheets & Cap Tables 3) Financials 4) Intellectual Property Protection 5) Leadership 6) Valuation & Price.  Free, a light lunch will be served. Parking is available in the garage adjacent to the Silver Spring Innovation Center.

BioMarker Strategies, LLC, a private company, has developed SnapPath®, a cancer diagnostics system that automates and standardizes functional ex vivo profiling of live solid tumor cells from fresh biopsies or other fresh, unfixed samples such as xenografts or tumorgrafts, according to the company’s website (see here: www.BioMarkerStrategies.com). SNNLive spoke with Jerry Parrott, President and CEO of BioMarker Strategies at the BioMaryland Booth at BIO International 2015 in Philadelphia, PA.

Revolve Biotechnologies, Inc. has been awarded a $450K Phase I Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH) – National Institute of Mental Health (NIMH) to develop iRFP-Max, a near-infrared fluorescent protein research tool that will enable in vivo imaging of brain and other tissues up to ten-fold deeper than currently available tools. Current fluorescent protein tools operate at wavelengths at which tissue absorbance allows scientists to image only close to the surface. This tool will enable a range of new applications and has the potential to become the industry standard for pre-clinical in vivo imaging for drug development and neuroscience research for diseases such as Alzheimer’s and Parkinson’s.

In 2011, the World Well being Group compiled an inventory of each illness, dysfunction, and ailment recognized to man. The listing ultimately crested the 14,000-ailment mark when it was full. However amongst all of those illnesses, it is debatable that none attracts extra consideration from drugmakers or the general public than most cancers.

Sept. 17th, 2015, Johns Hopkins Carey Business School, Washington DC, 1619 Massachusetts Ave NW Washington, DC, 20036

Are you an entrepreneur and thinking of starting your own company? Are you a small start-up looking for local resources that will help your company succeed? Are you a small company looking to expand and enter the next stage of commercial success? If you said “Yes” to any of these questions, then this WIB event is for you!

Our panel of industry experts from MD TEDCO, BioHealth Innovation, and the Montgomery County Department of Economic Development will provide you with invaluable information about resources their organizations provide to the local business community, including idea/product development, early and late stage funding, and business accelerator programs.

Pharmaceutical companies are running hard to keep pace with changes brought about by digital technology. Mobile communications, the cloud, advanced analytics, and the Internet of Things are among the innovations that are starting to transform the healthcare industry in the ways they have already transformed the media, retail, and banking industries. Pharma executives are well aware of the disruptive potential and are experimenting with a wide range of digital initiatives. Yet many find it hard to determine what initiatives to scale up and how, as they are still unclear what digital success will look like five years from now. This article aims to remedy that. We believe disruptive trends indicate where digital technology will drive the most value in the pharmaceutical industry, and they should guide companies as they build a strategy for digital success.

A Johns Hopkins spinout created to develop an ultrasound that works from inside the body closed a $500,000 seed round.

Perceptive Navigation, which is based at Johns Hopkins’ FastForward East incubator, received investment from the state-backed Maryland Venture Fund and the Abell Foundation.

Is the U.S. market for consumer wearable devices headed toward the trough of disillusionment on the Gartner Hype Cycle? A new report suggests that explosive growth in demand for fitness bands, smartwatches, smart glasses (think Google Glass) and the like peaked in January and has been headed downward ever since. 

QB3@953, a San Francisco, USA-based incubator created by QB3, a University of California research institute and biotech accelerator, has announced an agreement with UK pharma company GlaxoSmithKline (LSE: GSK).

Together the companies will identify and facilitate collaborations to translate early drug target concepts into medicines that benefit patients. It formalizes an existing relationship between QB3@953 and GSK’s Discovery Partnerships with Academia team.

On the surface of a living cell at any given time, hundreds of tiny bubbles are popping into existence, surrounding and incorporating proteins, hormones, fats, and the occasional bacteria or virus. But until now the details of this activity were inferred – you couldn’t actually see it. The problem wasn’t just that the structures taking part in this bustling activity are too small, but that our bodies work on an invisibly fast time scale—important changes are taking place over fractions of a second.

Symbiomix today announced the completion of patient enrollment in a Phase 3 clinical study, the second pivotal trial of SYM-1219, which is a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV). Earlier this year Symbiomix announced positive results from the first pivotal trial for SYM-1219. Symbiomix expects to finish this second pivotal trial by the end of 2015, which would enable a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA) in mid-2016.

Symbiomix also announced that the FDA has granted Fast Track designation to SYM-1219. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that are intended to treat serious conditions. Earlier this year Symbiomix announced that the FDA had designated SYM-1219 as a Qualified Infectious Disease Product (QIDP) for the treatment of BV. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review. Further, if ultimately approved by the FDA, SYM-1219 would be eligible for a five-year extension of exclusivity in addition to new chemical entity (NCE) market exclusivity.

Researchers from Johns Hopkins University have been working on a new solution for sepsis, a complication of infection that affects more than a million people in the U.S. each year and kills between 20 and 40% of them.

But this tool for treating sepsis isn’t strictly a medical intervention -- it’s a computer code.

Heading up the Johns Hopkins Medicine Technology Innovation Center, Gorkem Sevinc, MSE, CIIP, focuses the bulk of his attention on partnering with clinical and research personnel within Hopkins Medicine to collaboratively build innovative Health IT tools. Software development, IT infrastructure, workflow and collaboration tools are all part of his purview.

Sevinc started the informatics research laboratory in the Department of Radiology at Johns Hopkins Medicine along with his director and chair-elect of SIIM, Paul Nagy, PhD. They grew it to serve all of Johns Hopkins Medicine’s Health IT needs, but the department of radiology continues to be the lab’s anchor.

Baltimore Mayor Stephanie Rawlings-Blake has hired Jason Hardebeck to work on internet access issues for the city.

Hardebeck will serve as “Broadband Coordinator” for the city. He recently left his role as director of DreamIt Health Baltimore. The mayor made the announcement at a weekly media availability at City Hall.